BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7870072 · Received September 12, 2018

    Report

    Report Number
    2210968-2018-75715
    Event Type
    Injury
    Date Received
    September 12, 2018
    Report Date
    August 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: TURK J UROL 2017; 43 (4): 517-24; DOI: 10.5152/TUD.2017.29000. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: TRANSOBTURATOR FOUR ARMS MESH IN THE SURGICAL MANAGEMENT OF STRESS URINARY INCONTINENCE WITH CYSTOCELE." AUTHORS: HAMMOUDA SHERIF, TAREK SOLIMAN OTHMAN, AMR ELDKHAKHANY, HUSSEIN ELKADY, ADEL ELFALLAH. CITATION: TURK J UROL 2017; 43 (4): 517-24; DOI: 10.5152/TUD.2017.29000. THIS PROSPECTIVE STUDY AIMED TO EVALUATE SAFETY AND EFFICACY OF FOUR ARMS POLYPROPYLENE MESH IN MANAGEMENT OF STRESS URINARY INCONTINENCE (SUI) ASSOCIATED WITH CYSTOCELE DURING THE LONG TERM FOLLOW-UP. BETWEEN JUN 2013 AND SEP 2016, 50 FEMALE PATIENTS (MEAN AGE ± SD OF 47.6±6.4 YEARS [RANGED 35-65 YEARS]) WITH STRESS URINARY INCONTINENCE WITH CYSTOCELE UNDERWENT PLACEMENT OF TRANSOBTURATOR FOUR-ARMS MESH IMPLANTS USING MONOFILAMENT POLYPROPYLENE MESH OF GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM (INCLUDING NEEDLE GUIDE, CANNULA AND RETRIEVAL DEVICE). IN THE PROCEDURE, THE NEEDLE WAS PASSED WITH THE CANNULA THROUGH THE INCISED SKIN, AND ADVANCED UP TO THE OBTURATOR MUSCLE AND MEMBRANE. THEN IT WAS INSERTED THROUGH OBTURATOR FORAMEN AROUND ISCHIOPUBIC RAMUS TILL VAGINAL INCISION WAS APPROACHED UNDER GUIDANCE OF INDEX FINGER. THEN NEEDLE WAS REMOVED LEAVING THE CANNULA, IN WHICH THE RETRIEVAL DEVICE WAS PASSED FROM THE INCISED SKIN TO THE VAGINAL INCISION. THEN THE LOOPS OF THE RETRIEVAL DEVICE WERE PASSED THROUGH THE CANNULA AND THE UPPER ARM OF THE MESH WAS FIXED TO IT, AND BROUGHT OUT THROUGH THE CANNULA WHICH THEN REMOVED. THE SAME PROCEDURE WAS REPEATED ON THE OTHER SIDE. POSTOPERATIVE COMPLICATIONS INCLUDED FEVER AND URINARY TRACT INFECTION (N=5) WHICH IMPROVED USING ANTIBIOTICS AND ANTIPYRETICS; URINE RETENTION AFTER CATHETER REMOVAL (N=2) WHICH WERE TREATED WITH INDWELLING CATHETER FOR TWO WEEKS AND ADDITIONAL CLEAN INTERMITTENT FOR ANOTHER TWO WEEKS IN ONE PATIENT DUE TO RETAINED URINE AFTER INITIAL TREATMENT; GROIN AND THIGH PAIN (N=4) RELIEVED WITH ANALGESICS; AND VAGINAL MESH EROSION (N=1) WHICH REQUIRED LOCAL ESTROGEN CREAM WITHOUT ANY NEED FOR OPERATIVE INTERVENTION. TWO PATIENTS FAILED TO RESPOND TO TREATMENT AND DEVELOPED RECURRENT CYSTOCELES (POP-Q II AND III); THESE PATIENTS REFUSED TO UNDERGO FURTHER INTERVENTION. UROLOGISTS HAVE BELIEVED THAT DYSPAREUNIA IS NOT RELATED TO THE MESH ITSELF, BUT MAY BE DUE TO SOME POINTS IN THE TECHNIQUE. MANY STUDIES HAVE DEMONSTRATED THAT VAGINAL MESH DOES NOT SEEM TO CAUSE A NEGATIVE IMPACT ON SEXUAL FUNCTION, AND PROSPECTIVE COMPARATIVE STUDIES ASSESSING MESH AND TRADITIONAL REPAIR FOR THE ANTERIOR COMPARTMENT DEFECTS HAVE NOT DEMONSTRATED ANY SUBSTANTIAL DEVIATION IN THE RATE OF DYSPAREUNIA. CYSTOCELE ASSOCIATED WITH SUI CAN BE REPAIRED WITH TRANSOBTURATOR FOUR-ARM MESH GIVING BETTER RESULTS WITH IMPROVED QUALITY OF LIFE AND TOLERABLE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709740 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention